FDA Inspection
Geritrex CorporationGeritrex Corporation – FDA Inspection, Feb 2, 2018
Record Details
This FDA Inspection record concerns Geritrex Corporation, with an inspection on February 2, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 353c8f8f-bb9e-44a2-a14e-c15946f960fd
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1039787
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 211.94(b)Protection from external factors
- 21 CFR 211.125(c)Label reconciliation discrepancies evaluation/investigation
- 21 CFR 11Electronic records
- 21 CFR 211.110(c)In-process materials characteristics testing
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.125(a)Strict control not exercised over labeling issued
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Geritrex Corporation
5| Date | Classification | Office | Project area |
|---|---|---|---|
| April 18, 2018 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| October 19, 2015 | VAI | Center for Drug Evaluation and Research | Unapproved and Misbranded Drugs |
| March 21, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 7, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 14, 2009 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Geritrex Corporation
- FDA Inspection 1049910 - 2018-04-18
- FDA Inspection 951723 - 2015-10-19
- FDA Inspection 872376 - 2014-03-21
- FDA Inspection 710767 - 2011-02-07
- FDA Inspection 635067 - 2009-12-14
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